Kornimate/medical-research-clean huggingface dataset:
non-interventional study to collect real-world clinical and patient-reported outcomes in ovarian cancer

Conditions: Ovarian Cancer

Summary: this prospective non-interventional study is intended to generate new data and insights into first-line (1l) treatment of newly diagnosed advanced high-grade epithelial ovarian cancer (oc) in germany relevant for patients, physicians and payers. it will capture the influence of 1l poly adp ribose polymerase inhibitor (parpi) maintenance treatment (mtx) on medical routine in germany, especially on: * outcome of the 3-steps 1l treatment phase (including surgery, chemotherapy (ctx) and mtx) including the potential of patients with primary advanced oc to be cured, * patient's follow-up (fu) during and after mtx therapy, * patient-reported outcomes (pros), experiences and needs, * physician's experience, * brca/hrd and genomic scar testing behavior at diagnosis/during 1l therapy, * patient selection for different 1l systemic treatment approaches, * use and safety of drugs, * treatment sequence in case of recurrence


Eligibility criteria:
inclusion criteria: 1. signed written informed consent 2. women aged ≥ 18 years 3. newly diagnosed with primary advanced (figo stages iii and iv) high-grade epithelial ovarian cancer (including fallopian tube and/or primary peritoneal cancer) 4. for patients who qualify for primary debulking surgery, all surgical procedures must be completed prior to enrollment 5. brca mutation test (routinely analyzed germline and/or somatic brca1/2 status alone or as part of hrd status determination) already performed or initiated/intended 6. first-line platinum-based chemotherapy planned or a maximum of 3 cycles already received with no sign of disease progression. total number of cycles after enrollment should be decided individually for each single patient by the treating physician. in case of neoadjuvant chemotherapy and interval debulking surgery, the patient should be enrolled after completion of surgical procedure and at the time of the 1st post-surgery cycle of platinum-based chemotherapy. 7. willing and able to report pros electronically 8. women of childbearing potential must use two forms of reliable contraception according to standard of care exclusion criteria: 1. pregnancy or breast-feeding 2. current or planned participation in an interventional clinical trial on first-line treatment of oc 3. current or upcoming systemic treatment of any tumor other than oc 4. not eligible for platinum-based chemotherapy or early progress during the cycles of first-line platinum-based chemotherapy prior to enrollment -

Keywords: patient reported outcome (pro), advanced ovarian cancer
validity of cardiac output measurement using niccomo device after cardiac surgery

Conditions: Shock, Cardiogenic; Surgery; Output, Low Cardiac

Summary: cardiac surgery is at high risk of low cardiac output syndrome after procedure. monitoring cardiac function, and especially cardiac output, is important to identify cardiovascular dysfunction and to introduce and adjust optimal therapies. invasive monitor such as pulmonary arterial catheter or transpulmonary thermodilution provide precise measurements but need an invasive access to arterial and central venous route, with possible complications. cardiographic bioimpedencemetry (niccomo device, imedex corp) allows a non invasive measurement of cardiac output and some other parameters of cardiovascular function. nevertheless, the reliability of this device has been little studied after cardiac surgery.


Eligibility criteria:
inclusion criteria: * age \> 18 y/o * patients benefiting from cardiac surgery and pulmonary arterial catheter monitoring exclusion criteria: * aortic regurgitation grade 3-4 * uncontrolled hypertension (map \> 130 mmhg) * circulatory or cardiac assistance * active pacemaker
a research study comparing blood levels of medicines nnc0194-0499 and semaglutide administered as a combination formulation versus two separate formulations

Conditions: Non-alcoholic Steatohepatitis

Summary: novo nordisk is developing a combination of 2 medicines (nnc0194-0499 and semaglutide) for the treatment of nonalcoholic steatohepatitis (nash). nash is a serious disease where fat, inflammation and scar tissue builds up in the liver. nnc0194-0499 is a new medicine which works in the liver. semaglutide is a well-known medicine, which is already used to treat type 2 diabetes and obesity. the study is being done to see how 2 medicines (nnc0194-0499 and semaglutide) are absorbed, transported, and eliminated from the body in a combination formulation. participants will either get nnc0194-0499 and semaglutide in a combination formulation or the separate formulations. which treatment participants get is decided by chance. the study will last for either 13 or 33 weeks. the duration is decided by chance.


Eligibility criteria:
inclusion criteria: * male or female * aged 18-55 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between greater than or equal to 25 and less than or equal to 35 kilogram per meter square (kg/m\^2) (both inclusive) * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator exclusion criteria: * known or suspected hypersensitivity to study intervention(s) or related products * female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method * participation (that is, signed informed consent) in any other interventional clinical study within 90 days before first trial product administration (visit 2, day 1) * use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol, acetylsalicylic acid within 14 days before first trial product administration (visit 2, day 1)
a study to assess rad011 (cannabidiol oral solution) for the treatment of participants with prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: this was a study investigating rad011 in participants diagnosed with prader-willi syndrome (pws). the primary objective of the phase 2 part of this study was to assess the safety and tolerability of multiple dose levels of rad011 in order to select 1 or 2 dose level(s) for further evaluation in the phase 3 part of the study. in phase 3, the primary objective was to assess the effect of rad011 on hyperphagia-related behavior in participants with pws.


Eligibility criteria:
inclusion criteria: * males and females between 8 and 65 years of age (inclusive) at screening. * genetically confirmed diagnosis of pws. documentation of genetically confirmed diagnosis of pws is acceptable. * the same caregiver is available to complete the questionnaire throughout the duration of the study. * after completion of the tolerability period, participants will have a mean hyperphagia questionnaire for clinical trials (hq-ct) score ≥13 and a decrease of hq-ct score no more than 7 during tolerability (run-in) period. * if receiving growth hormone, psychotropic therapy, metabolic treatments that could affect appetite (including metformin), and other treatment including thyroid hormone, must be on the same medication and dose for at least 90 days prior to consent/assent exclusion criteria: * known use of cannabis or cannabinoid containing products (including topical products) within 90 days prior to consent/ assent. * use of prescription or over-the-counter weight loss agents within 90 days prior to consent/assent. * implementation of new food or environmental restrictions within 90 days of consent/ assent. * if living in a group home, participant spends less than 25 waking hours with their caregiver per week. * uncontrolled chronic conditions (diabetes, sleep apnea, etc.) as determined by the investigator.
a study to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of vanzacaftor/tezacaftor/deutivacaftor(vnz/tez/d-iva)

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of vnz/tez/d-iva.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 32.0 kilogram per meter square (kg/m\^2), both inclusive * a total body weight greater than (\>)50 kg key exclusion criteria: * history of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * any condition possibly affecting drug absorption * female participants who are pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug * male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug other protocol defined inclusion/exclusion criteria may apply.
investigate the effect of azd1656 on the pharmacokinetics and pharmacodynamics of warfarin in type 2 diabetes mellitus (t2dm) patients

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine whether azd1656 will affect the pharmacokinetics and pharmacodynamics of warfarin in t2dm patients.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of t2dm treated with at least 1000 mg metformin as a single treatment or in combination with one other oral anti-diabetics for at least 2 months prior to screening. doses of anti-diabetic treatment stable for at least 1 month * fasting plasma glucose (fpg) at screening in the range of 6.0 to 15.0 mmol/l (108 to 270 mg/dl) and fpg in the range of 7.5 to 13.0 mmol/l (135 to 234 mg/dl) on day 1 * haemoglobin (hb) a1c \>6.5% at screening exclusion criteria: * use of drugs with anticoagulant effects 3 weeks prior to first warfarin dosing * use of amiodarone within 3 months prior to screening and the use of potent cyp450 inhibitors * previous treatment with warfarin on clinical indication

Keywords: diabetes type 2 warfarin drug-drug interaction
multimodal pet imaging in the diagnosis and treatment of pelvic tumors

Conditions: Endometrial Cancer

Summary: this study is a prospective exploratory study to explore the application value of gallium 68 labeled-fibroblast activation protein inhibitor-04 positron emission tomography（68ga-fapi-04 pet）imaging in patients with endometrial cancer and compare it with the imaging agent with better imaging effects to study its advantages. after patient enrollment, 68ga-fapi-04 positron emission tomography/computed tomography（pet/ct） and positron emission tomography/magnetic resonance imaging（pet/mri） examinations are performed, with the imaging agent administered intravenously at a dose of 0.02 to 0.04 mci/kg×patient weight (kg), and a whole-body scan is performed 30-60 minutes later, with images processed as usual. within 1 week before and after the examination, fluorine18 labeled-fluorodeoxyglucose positron emission tomography/computed tomography（18f-fdg pet/ct） is completed, along with medical history collection and necessary laboratory tests. subsequently, patients undergo surgical resection of the lesion and suspicious metastatic lymph nodes shown by fapi pet/ct to obtain the corresponding pathological results. finally, the diagnostic value of all patients in 68ga-fapi-04 pet/ct and pet/mr is analyzed and compared with 18f-fdg pet/ct to study the differences in diagnostic efficacy between the two.


Eligibility criteria:
inclusion criteria: * 18-70 years old * obtaining written informed consent * being able to accept follow-up * feasible surgery or biopsy to obtain the final result exclusion criteria: * pregnant and lactating female patients * patients who are difficult to receive further diagnosis and treatment due to their severe condition * any patients with contraindications to magnetic resonance imaging
acute effects of rhbnp in patients with ph associated with acute exacerbation of chronic pulmonary disease

Conditions: Pulmonary Hypertension

Summary: to evaluate the acute effect of recombinant human brain natriuretic peptide(rhbnp) on pulmonary hypertension of acute exacerbations of chronic pulmonary disease. rhbnp was administered as a continuous infusion for 24 hours , pulmonary artery pressure and other hemodynamic parameters were monitored by swan- ganz catheter.

pulmonary hypertension (ph) is a descriptive name for abnormally elevated pressures in the pulmonary vasculature, which seriously affects the quality of life and survival of patients. currently, no effective drugs treatment was used in patients with pulmonary hypertension due to acute exacerbation of lung disease. recombinant human brain natriuretic peptide (rhbnp)was approved in 2001 for use in patients with acute heart failure on the basis of studies showing a reduction in pulmonary-capillary wedge pressure(pcwp) and pulmonary arterial pressure (pap) and improvement cardiac output (co) . thus, the study was designed to administer rhbnp as a continuous infusion for 24 hours on pulmonary hypertension of acute exacerbations of chronic pulmonary disease monitoring by swan- ganz catheter. each patient was studied on two occasions (6 hours apart). one occasion the subject received rhbnp 1.5ug/kg iv bolus followed by an infusion of 0.0075ug/kg/min for 24 hours; other occasion the subject received iv placebo bolus followed by a placebo infusion for 24 hours .these were administered in random order in double blind fashion.

Eligibility criteria:
inclusion criteria: 1. age\>18 years old, male or female; 2. in acute exacerbation period and with a history of chronic respiratory diseases; 3. cardiac ultrasound showed a pulmonary hypertension ≥50mmhg; 4. grade ii or who grade of heart function; 5. signed informed consent. exclusion criteria: 1. pulmonary hypertension not associated with chronic lung disease; 2. acute or severe chronic left heart failure; 3. severe respiratory failure during receipt of non-invasive or invasive ventilator therapy; 4. mpap≤25mmhg or pulmonary capillary wedge pressure (pcwp) ≥15mmhg at rest as assessed by swan- ganz catheter; 5. a high risk of hypotension (systolic pressure \<100 mmhg or 110 mmhg with the use of intravenous nitroglycerin); 6. uncontrolled arterial hypertension; 7. acute coronary syndrome; 8. severe left ventricular hypertrophy; 9. congenital or acquired valvular or myocardial disease; 10. end-stage renal disease during receipt of renal replacement therapy; 11. clinically significant anemia; 12. other contraindications for vasodilators; 13. treatment with dobutamine (at a dose ≥5 μg per kilogram of body weight per minute); 14. treatment with milrinone or levosimendan within the previous 30 days.
von willebrand factor as a biological sensor of blood flow in percutaneous cardiac procedure

Conditions: Heart Failure; Aortic Stenosis

Summary: the witavi study was designed to explore the kinetic and associated outcome of von willebrand factor-multimerizaton defects associated with devices in cardiovascular diseases.

this study was designed to understand the von willebrand factor (vwf) abnormalities observed in association with implantation of different devices in cardiovascular diseases (percutaneous valve replacement and circulatory support devices). the main objective of the study was to describe the time-course of vwf abnormalities onset/offset during implantation of devices in cardiovascular diseases. adult patients \> 18 years who need a cf-lvad or trans-aortic valve implantation are included in this cohort; blood samples are obtained just before procedures

Eligibility criteria:
inclusion criteria: * adult patients \> 18 years who need a mechanical circulatory support due to advanced heart failure or undergoing trans-aortic-valve-replacement to treat aortic stenosis. * informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated) exclusion criteria: * patient with a known severe bleeding disorder * patient refusal or environment * minor patients * pregnant women

Keywords: acquired von willebrand trans aortic valve replacement mechanical circulatory support
lingual frenum and articulation of phonemes

Conditions: Speech Disorders

Summary: purpose to investigate the relationship between lingual frenum and possible alterations in the articulation of phonemes. methods this is a quantitative observational study, the individual operative kind with transversal time reference. the population sample consisted of 16 individuals, each one with their phonological system complete. the data were captured through an application form that contained relevant aspects as to the qualitative-classification of the lingual frenum, quantitative-relation of mouth opening, with and without the tongue in the papillae, tongue mobility and ert - 78 phonologically balanced words.

the data were captured through an application form that contained relevant aspects as to the qualitative-classification of the lingual frenum, quantitative-relation of mouth opening, with and without the tongue in the papillae, tongue mobility and ert - 78 phonologically balanced words.

Eligibility criteria:
inclusion criteria: * patients with the frenulum of the tongue - the presence of the central incisors and upper and lower side exclusion criteria: * patients in speech therapy aimed at enabling oral motor or speech - without integrity orofacial motor - patients using grid palate - with changes in the temporomandibular joint - anterior open bite

Keywords: tongue frenum lingual frenum audio phonology speech disorders
a study with glpg1972 in osteoarthritis subjects

Conditions: Osteoarthritis

Summary: this is a randomized, double-blind, placebo-controlled, stratified, ascending dose, single center study, in three semi-sequential cohorts of 10 male and female subjects of nonchildbearing potential with osteoarthritis (oa), administered glpg1972 or placebo. per cohort, 10 subjects will be randomized in a 4:1 allocation ratio to active treatment with glpg1972 or matching placebo. in each cohort, oa subjects will be stratified for age (50- 64 years and 65-75 years) with a minimum of 2 of each sex per age group.


Eligibility criteria:
inclusion criteria: 1. male or female subjects of non-childbearing potential, 50-75 years of age on the date of signing the informed consent form (icf), inclusive extremes. 2. diagnosis of oa (knee and/or hip) made by their physician based on symptoms, clinical signs and documented historical imaging evidence. 3. a body mass index (bmi) between 18.0 and 34.9 kg/m2, inclusive extremes. 4. judged to be in age-appropriate good health by the investigator based upon the results of a medical history, physical examination, vital signs and 12-lead ecg, and fasting clinical laboratory profile. 5. subjects with a stable chronic illness at least 3 months will be accepted subject to the investigator's judgment. exclusion criteria: 1. administration of intraarticular glucocorticoid injections or hyaluronan injections in the last 3 months prior to study screening. 2. subjects who underwent or are on a waiting list for total hip or knee replacement and any other surgery planned during the study (up to day 50). 3. known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization. 4. positive serology for hbsag or hcv antibody or history of hepatitis from any cause with the exception of hepatitis a. 5. history of or a current immunosuppressive condition. 6. clinically significant serious, per investigator's discretion, and/or unstable illness in the 3 months before screening 7. renal function with an estimated creatinine clearance \< 60 ml/min based on the cockcroft-gault formula. retesting is allowed once (see section 5.2). 8. use of verapamil, diltiazem, amitriptyline, warfarin, acenocoumarol, phenobarbital and phenytoin, within 4 weeks before first study drug administration 9. consumption of herbal medications that are strong inhibitors and/or inducers of cyps (e.g., st. john's wort) and grapefruit/grapefruit products, seville oranges, or any poppy seed, within 7 days prior to the first study drug administration. 10. history of solid organ or hematopoietic cell transplantation. 11. history of malignancy within the past 5 years. 12. clinically significant abnormalities detected on 12-lead ecg of either rhythm or conduction (e.g., qtcf ≥ 450 ms for males and qtcf ≥ 470 ms for females, or a known long qt syndrome). 13. significant blood loss (including blood donation \[\> 450 ml\]), or transfusion of any blood product within 12 weeks prior to screening
use of a collagen membrane for soft tissue grafting

Conditions: Localized Gingival Recession

Summary: is primatrix wound dressing capable of regenerating gum tissue inside the mouth?

primatrix is an acellular fetal bovine dermal matrix that has a wide array of fda approved uses. these uses include partial- and full-thickness wounds, pressure, diabetic, and venous ulcers, surgical wounds, trauma wounds, tunneled wounds, and draining wounds. it is a sheet-like matrix made up primarily of type i and type iii collagen. an increased proportion of type iii collagen appears to play a key role in healing and regeneration. the use of extracellular dermal matrices is a relatively young field, and the exact mechanism by which primatrix promotes skin regeneration is still unknown. despite this, primatrix has demonstrated differences in manufacturing and molecular composition that make it conducive to the harsh environments in which it has already been tested. intraorally, where there is a rich vascular bed, this material holds exceeding promise. utilizing this vascularity, autogenous free gingival grafts from the palate have already had their efficacy proven as a method of augmenting the keratinized tissue.the need to increase the keratinized tissue is based upon the postulation that less mobile, keratinized epithelium is more resilient than the non-keratinized oral mucosa. this is especially important in areas where recession and attachment loss has already occurred. without having keratinized gingiva apical to the recession area, it has been suggested that there is a greater risk for more attachment loss to occur, thus reducing the support for the tooth. in addition, autogenous free gingival grafts have demonstrated the phenomenon of "creeping attachment" where a portion of the recession actually becomes covered as a result of grafting. while autogenous grafting is the gold standard in soft tissue augmentation, the amount of tissue that can be taken from the palate is limited, making it difficult to treat patients with generalized recession. furthermore, a secondary surgical site increases the morbidity associated with the procedure. the hypothesis of this study is that primatrix will be able to provide similar results to an autogenous free gingival graft.

Eligibility criteria:
inclusion criteria: * must have one to three consecutive teeth with recession and less than 1 mm of keratinized gingiva exclusion criteria: * asthma * pregnancy * uncontrolled diabetes * use of continuous positive airway pressure (cpap) machine for sleep apnea * oral appliances (removable partial dentures, braces, mandibular advancement, bruxism splints, etc.) * tobacco use * immunocompromised individual